BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 1841947 · Received September 21, 2010

    Report

    Report Number
    1644487-2010-02136
    Event Type
    Injury
    Date Received
    September 21, 2010
    Date of Event
    August 7, 2010
    Report Date
    August 23, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT CAN NO LONGER PERCEIVE STIMULATION AND HAS EXPERIENCED EIGHT SEIZURES OVER A FOUR DAY PERIOD. THE PT CAN FEEL STIMULATION WHEN THE MAGNET IS SWIPED. THE PT STATED THAT THE PHYSICIAN FEELS THAT THE SEIZURES ARE DUE TO END OF SERVICE BUT FURTHER CLARIFICATION ON HOW THIS WAS DETERMINED ALONG WITH ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE. THE PT HAS BEEN REFERRED FOR A SURGICAL CONSULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 LYJ CYBERONICS, INC. 101 1202

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR